Sr. Quality System Specialist (Remote/Flexible)

This Sr. Quality System Specialist (Process Excellence) is responsible for ensuring quality system compliance within the Production and Process sub-process for governance and governance of
related quality systems. The Sr. Quality Systems Specialist will partner with “process owners” to identify best practices, harmonize where appropriate (and where not to) and implement improvements to be documented into Policies, Procedures, and Work instructions that define how Insulet manages the supply chain within “Production and Process Controls” to include: 

• Work Environments

• Calibration and Equipment Controls

• Microbiology and Sterilization

• Process Controls

• Process Validation

• Acceptance Activities

• Identification and Traceability

• Product Storage

• Handling, & Distribution Controls

• Servicing

This effort requires a broad skill set for facilitation, communication, and understanding of various Int’l regulations and standards to improve the quality management system. Effectively communicating quality system, requirements, optimizing development. Also,  review and ensuring ambiguities and conflicting requirements are resolved is critical to the success of
the position.

Responsibilities:

• Create and update quality system and related quality system documents.
• Develop and work w/ Training department to deploy training for these documents.
• Review and approve Quality Management System documents and protocols.
• Supporting remediation activities as needed.
• Support the development of workflows in these systems.
• Support resolution of issues with nonconformances in various processes

• Support internal and external quality system audits and related Root Cause Analysis, CAPA, and implementation activities.
• Review and approve new product documentation, as required.
• Support Risk Management activities and ensure compliance to standards and regulations.

Education And Experience minimum requirements:

• BS degree, in an Mechanical, Biomedical, engineering/life sciences curriculum,  or quality management curriculum or equivalent experience.
• A minimum of 5-7 years’ work experience in Quality Assurance within an FDA, ISO or other regulated environment and/or equivalent combination of education and experience.

Preferred Skills and Competencies:

• Experience in the development and implementation of effective Production and Process Control system within a Quality Management System.
• Experience in the development and implementation of effective Design Control Systems.
• Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820), ISO 13485 Medical
devices – Quality management systems, and ISO 14971 Medical devices – Application of risk management to medical devices.
• Fluent in computer skills, and at minimum, the use of Microsoft Office programs (e.g. Word, Excel, Visio, PowerPoint),

• Ability to effectively communicate with all levels of employees from front line operators up to and including Vice Presidents/Executives

• Ability to work independently and follow up with task owners to complete tasks and close out open items.
• Familiarity with structured phase-gate product development processes.
• Familiarity with FDA, ISO, and other international regulatory requirements.
• Experience collaborating and communicating with individuals in multiple departments and at multiple levels in an organization.

• Previous experience in a management position a plus but not required
• Auditor training certification to ISO 13485, 17025 or other industry QMS Standard
• CQE, CQM, CQA, Greenbelt or above, and / or PMP certifications a plus
• Strong verbal and written communication skills.
• Ability to organize and judge priorities.
• Able to work effectively in a high-stress, high-energy environment.
Physical Requirements
• Travel as required to support business needs, up to 25%

NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired). #LI-Remote 

Additional Information:

The US base salary range for this full-time position is $89,775.00 - $134,662.50. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition S